A Phase 4 interventional study of Vitis vinifera extract and Calcium Dobesilate in Diabetic Retinopathy, sponsored by Hanyang University. Completed. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-05-24.
Sponsored by Hanyang University · Phase 4, Interventional, and Treatment
This was a multicentre, randomised, double-blind controlled study that compared the efficacy and safety of V. vinifera extract, calcium dobesilate (CD), and placebo in subjects with DME. Patients made 6 clinic visits, namely the screening visit; baseline visit (T0); and follow-up visits at 3 (T3), 6 (T6), 9 (T9), and 12 (T12) months.
Eligible patients were randomised to one of the three study groups in a 1:2:2 ratio (placebo:GSPE:CD group). The randomization schedule was generated and prepared using cubeIWRS® solution (CRScube Inc., Seoul, South Korea, HQ). Randomization was performed using a complete randomization algorithm according to the order of the baseline visit. Subjects took three tablets of a masked study medication three times daily for 12 months; the first dose was taken in the morning of the baseline visit (T0) after baseline assessments were performed, and the last dose was taken in the evening before the month 12 visit (T12). Three daily oral doses of 50mg tablets of GSPE (Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in the GSPE group. Placebo tablets lacked GSPE, but their appearance was identical to that of the study group tablets. Commercially available 250mg CD tablets (Doxium®, Ilsung Pharm, Seoul, South Korea) were used in this study. The identity of the masked study medications was concealed by storing the medications in individually sealed envelopes at the study sites.
815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.
This study's enrollment of 153 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.
Browse Retinal Diseases studies →Hanyang University is the lead sponsor of 51 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Three daily oral doses of 50mg tablets were administered to patients
Drug: Vitis vinifera extract
Three daily oral doses of 250mg tablets were administered to patients
Drug: Calcium Dobesilate
Three masking tablets were administered to patients
Drug: Placebo
Three daily oral doses of 50mg tablets of Vitis vinifera extract(Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in this group
Also known as: Experimental: Entelon
Three daily oral doses of 50mg tablets of Calcium Dobesilate(Doxium®, Ilsung Pharm, Seoul, South Korea) were administered to patients in this group
Also known as: Active comparator:Doxium
Placebo tablets lacked Vitis vinifera extract or calcium dobesilate, but their appearance was identical to those of the study group tablets.
Also known as: Placebo comparator:Placebo
The change(Improvement)in the hard exduates
The improvement of HE was defined as a decrease in the HE severity by at least two categories of severity at T12 compared with the baseline visit.
Time frame: T0(baseline), T12(12months)
The change of Best-corrected visual acuity(BCVA)
Using the Early Treatment Diabetic Retinopathy Study(ETDRS) protocol
Time frame: T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)
The change of central subfield mean thickness(CSMT)
Using 6-radial scan protocol or cube scan protocol according to local guidelines of each center;the ETDRS style map
Time frame: T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)
The change of total macular volum(TMV)
Using 6-radial scan protocol or cube scan protocol according to local guidelines of each center;the ETDRS style map
Time frame: T0(baseline), T3(3months), T6(6months), T9(9months), T12(12months)
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Hanyang University